Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced Valneva SE has initiated a pivotal Phase 3 clinical trial for its inactivated, COVID-19 vaccine candidate, VLA2001, using Dynavax's CpG 1018 adjuvant. The Phase 3 trial "Cov-Compare", (VLA2001-301), will compare Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria, in a comparative immunogenicity trial.
The initiation of the Cov-Compare trial follows positive initial results from Valneva's Phase 1/2 clinical trial, which demonstrated that the safety profile and immunogenicity were supportive of further development.
Cov-Compare (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in approximately 4,000 adults. Its primary objective is to demonstrate the superiority of VLA2001 compared to Vaxzevria administered in a two-dose immunization schedule four weeks apart, in terms of Geometric Mean Titer ratio of SARS-CoV-2-specific neutralizing antibodies at two weeks after the second vaccination (i.e. Day 43) in adults aged 30 years and older. It will also evaluate the safety and tolerability of VLA2001 at two weeks after the second vaccination in adults aged 18 years and older.
The trial will be conducted at approximately 25 sites in the U.K. and is supported by the U.K. National Institute for Health Research. Approximately 3,000 participants 30 years of age and older will be randomized in a 2:1 ratio to receive two intramuscular doses of either VLA2001 (n=2,000) or Vaxzevria (n=1,000) at the recommended dose level, 28 days apart, on Days 1 and 29. For immunogenicity analyses, samples from approximately 1,200 participants (600 per group) who have been tested sero-negative for SARS-CoV-2 at screening will be analyzed. Approximately 1,000 participants that are under 30 years of age will be placed in a non-randomized treatment group and receive VLA2001 28 days apart.
Subject to successful Phase 3 data, Valneva intends to make a regulatory submission in the autumn of 2021 for initial approval.
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